ML17338B080

Summary of Meeting on Digital Instrumentation and Control Integrated Action Plan Modernization Plan 4

ML17338B080
Person / Time
Issue date:	05/01/2018
From:	Lynnea Wilkins NRC/NRR/DLP/PLPB
To:	Dennis Morey NRC/NRR/DLP/PLPB
Wilkins L
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Download: ML17338B080 (7)

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May 1, 2018 MEMORANDUM TO: Dennis Morey, Chief Licensing Processes Branch Division of Licensing Projects Office of Nuclear Reactor Regulation FROM:

Lynnea E. Wilkins, Project Manager /RA Serita Sanders for/

Licensing Processes Branch Division of Licensing Projects Office of Nuclear Reactor Regulation

SUMMARY

OF NOVEMBER 16, 2017, MEETING ON DIGITAL INSTRUMENTATION AND CONTROL INTEGRATED ACTION PLAN MODERNIZATION PLAN #4 On November 16, 2017, U.S. Nuclear Regulatory Commission (NRC) staff met with representatives from the Nuclear Energy Institute (NEI) to continue discussions of short-term aspects of Modernization Plan #4 (MP #4) of the Integrated Action Plan to Modernize Digital Instrumentation and Controls (DI&C) Regulatory Infrastructure (Agencywide Documents Access and Management System (ADAMS) Package Accession Number ML17102B296). The purpose of the meeting was to discuss and further develop a revision to the current guidance for license amendments that include DI&C safety equipment (DI&C-ISG-06). The discussions focused on actions from prior meetings, and developing and refining the revised guidance.

At the start of the meeting, the project scope of the DI&C-ISG-06 revision activity and progress to date were summarized. This scope included incorporating lessons learned from review process experiences with DI&C-ISG-06 and adding an alternate review process for safety systems to be implemented using a previously reviewed and approved instrumentation and control (I&C) platform. The alternate review process will provide the information necessary to reach a safety conclusion within the license amendment request rather than at a later phase of life cycle development. Additionally, the alternate review process allows a license amendment based substantially on system design information, and absent many hardware or software design and implementation details, or subsequent test results. Creation of the draft revision by early 2018 will support a late 2018 license amendment request to use the alternate process.

Additionally, the use of the term system level design to characterize the information supporting the alternate review process was discussed during this meeting. In response, NEI indicated that more than the system design information, as necessary, was intended to support the proposed alternate review process.

CONTACT: Lynnea E. Wilkins, NRR/DLP/PLPB 301-415-1377

Furthermore, there was discussion on the merged ISG-06, which included clarity and alignment on the information that would be provided in the license amendment request as sufficient to evaluate the application against regulatory requirements to reach the safety conclusion. The proposed ISG-06 uses the term system level design to characterize this information. Based on licensing experiences, the NRC reiterated that licensees often reference design information at a level lower than system to demonstrate regulatory compliance. The NRC also pointed out that some lower level information would likely be available within the desired review and license amendment issuance timeframe (one year or less) that industry is seeking. NEI acknowledged that system level design information may not be the most accurate characterization, industry would provide the necessary and sufficient information in the license amendment request, and some of this information likely would be lower than the system level. NEI stated that the alternate review process is intended to be different from past practice, so licensees would need to meet the new expectations of the alternate review process.

During these same discussions, industry emphasized that the level of information described under ISG-06 for the alternate review process is intended to encompass all information that should be provided in the license amendment request. To resolve this comment, two actions were proposed: 1) NEI would draft some general language to cover necessary and sufficient information in the license amendment request regardless of design level (rather than attempt to detail the information within the body of the ISG); and 2) NEI would review the use of system level design within ISG-06 and consider proposing some alternate wording that might better align with industrys intent and avoid potential confusion during future uses of the alternate review process. As part of these actions, developing a written definition that characterizes industrys intent for system level design information and architecture level information may be considered. NRC and NEI agreed that ambiguous wording within ISG-06 should not be a driver of substantial requests for additional information. In other words, when a licensee proposes to use the alternate review process, the acceptance review process should limit the requests for additional information by ensuring the license amendment request content meets the alternate review processs expectations. As such, any subsequent requests for additional information would largely be limited to areas where specific alternate review process guidance needs to be addressed.

NRC and NEI reviewed and discussed the following:

a. Recent and proposed updates to the project plan and its execution;

b. The near-complete DI&C-ISG-06 draftthat merged previously drafted, reviewed and edited sectionsfocusing on discussions to clarify specific comments;

c. D.5 - using NRC-approved topical reportthat was drafted by NEI for initial discussion;

d. The prerequisites for using the alternate review process - examples of prerequisites included proposed license commitments and conditions, which would address post licensing activities, including plant specific activities identified in the NRC-approved topical reports (previously referenced).

NRC and NEI reviewed, discussed and annotated the project plans proposed milestones and dates. The NRC presented dates for other NRC project milestones, which had been noted as to be determined. The NRC and NEI discussed adjusting the milestones for industry confidence in the drafted ISG-06, and a lead plant pre-application meeting using the alternate review process. The confidence version of the draft ISG-06 was changed to December 1, 2017, and the lead plant date was estimated to be late 1st quarter / early 2nd quarter of calendar year

2018. To better understand and clarify the edits to the project plan, it was agreed that the entries based on projected dates would be rearranged such that items in the project plan would again be time-ordered.

In preparation for early informal circulation of the draft ISG-06, the NRC proposed the creation of a one-pager to accompany the draft that could be used to support subsequent briefings of the scope and nature of the ISG-06 revision. NEI agreed to support development of the NRC one-pager. This approach will likely ensure industrys intent for the creation of an alternate review process remains clear. The one-pager should be clear enough to allow subsequent comments to be assessed for likelihood of acceptability by industry.

NEI led the review and discussion of NRC comments on the merged near-complete ISG-06 draft. This discussion was limited to comments and resolutions for which industry sought either further clarification or that might require significant effort to resolve.

The discussion of the merged ISG-06 also included adherence to prior general agreements to avoid references to existing standard or guidance in consideration that a mapping to IEEE standards 603 and 7-4.3.2 is established within ISG-06.

During the discussion of the merged ISG-06, two working agreements were identified and a third was proposed. The two working agreements were: 1) the tactical ISG-06 revision would exclude improving guidance on the review of topical reports (i.e., would be limited to license amendment requests); and 2) the license review process covered by ISG-06 will end at the issuance of the license amendment rather than the NRC I&C staffs issuance of a safety evaluation report. The merged ISG-06 will be reviewed and made consistent with these agreements, which should simplify wording to clarify ISG-06 is intended for licensees and NRC staff for digital safety system license amendments. The proposed agreement, if moved forward, would further limit the use of the alternate review process to cases where the vendor of the referenced NRC-approved topical report platform also supplies the application. This limitation could become an additional alternate review process prerequisite. This prerequisite could further leverage previously NRC-approved topical report processes and procedures while simplifying related ISG-06 wording. NEI took an action to determine whether this proposal should become an additional alternate review process prerequisite.

NEI led the review and discussion of NRC comments to the initial Section D.5, which addresses alternate review process use of an NRC-approved I&C platform topical report. During the conversations changes were reviewed and proposed to address NRC comments. Discussions focused on clarifying comments and their resolution. Neither NEI nor NRC identified any comment as significant or requiring substantial effort to resolve.

NEI led a review and discussion of its revised prerequisites to use an alternate review process.

NEI expressed its intent is to propose licensing commitments for license conditions consistent with Section 4.4 of LIC-101, License Amendment Review Procedures (ADAMS Accession No. ML16061A451). Under the alternate review process, the described commitments would be proposed within the license amendment request to address closure of application specific action items and late stage detailed design, implementation, and test activities under the licensees quality assurance program. However, the details of the associated vendor oversight processes and procedures, which address specific Quality Assurance Requirements for Nuclear Facility Applications (NQA-1) software process topics, will reside outside the licensees top level quality assurance program document. NRC staff will use the information provided in this section to

engage the NRC licensing office, inspection staff, and the Office of General Counsel (OGC) on the acceptability of the proposed approach.

Actions resulting from this meeting are as follows:

1) NRC and NEI - Updates to the Project Plan (by 11/21/17 unless otherwise noted)

a. NEI - Add a separate milestone in the Project Plan for engaging DORL similar to the milestones for the OGC and Inspection Branch.

b. NRC - Identify all stakeholders within the agency for this ISG and add the necessary entries to the Project Plan. (by 12/14/17)

c. NEI - Add separate milestone in the Project Plan for ISG-06 draft Rev. 0 Complete (before January 2018).

d. NEI - Change Project Plan to state NRC "publishes" rather than "issues" ISG.

e. NEI - Rearrange Project Plan schedule, so that it is sequential in time with appropriately ordered identifiers. (by 11/28/17)

2) NEI - Provide a one page summary of the revised ISG-06 to accompany the revised document. The one page document will describe industry goals and how ISG-06 accomplishes those goals. (by 11/27/17)

3) NEI - Document comment resolutions (by comment id where included): (by 11/21/17)

a. SR 54 - Delete the sentence. Reword subsequent sentences so that it only describes an early review and approval.

b. Change figure to say "License Amendment". Complete and Install block should be changed to Install.

c. ZD1 - Add that the alternate review process relies on an approved topical report.

d. DB28 - Move to the introduction section describing the Phase 0 or pre-application meeting. Describe how tools used for sharing files will be used.

4) NEI - Draft proposed wording to address general caveat for sufficient information in support of Action 5 a & b) (by 11/21/17)

5) NEI - Action to consider how the use of system (as in system design and system level design) in the alternate process should be revised to ensure clarity, in further consideration of an additional statement at the beginning of the ISG description for the Alternate Review Process that covers the following ideas: (by 12/5/17)

a. The information provided in the license amendment request should include sufficient design detail for the NRC staff to reach a safety determination and conclusion.

b. Any information not provided for the NRC staff to reach a safety determination and conclusion will be requested by the staff via a request for additional information.

6) NRC - Identify and provide an example illustrating where the level of detail provided in a license amendment request (e.g., as part of system level requirements) was insufficient and required requests for additional information. (by 11/21/17).

7) NRC and NEI - In consideration of the wording from Action 4) (as refined), Action 5) and the and example from Action 6), determine whether the following should be pursued. (by 12/5/17):

a. Identification of specific areas in the ISG-06 draft that seem to have holes in the level of detail that a licensee might provide based on its guidance

b. Identification of specific attributes of Software Requirements Specifications that are required to make a safety determination.

8) NEI - Provide a complete version of the ISG-06 draft. (by 11/21/17)

9) NEI - In changing and describing Alternate Review Process, convey the alternate process will be more detailed than typical system level design information provided under Tier 1.

This action should also address comment P66 - Change to Alternate Tier 1 to Alternate Review Process (global change) (by 11/27/17).

10) NRC - Staff to reach consensus on the extent to which the ISG revision should restate underlying regulation when pointing to regulatory guidance or industry standards (ZD46).

Global comment. (by 12/5/17)

11) NEI - Explain how diagnostics are part of the architecture and why they are important to the system architecture description. In doing so, make the connection to the underlying regulation that the description of diagnostics within the architecture is essential to address (ZD 55). (by 11/28/17)

12) NRC - Update industry on NRCs discussions of the proposed alternate review process approach. (by 12/5/17)

13) NRC and NEI - Review the 11/22 draft of the ISG including identification of any potential major concerns or show stoppers (by 12/5/17).

14) NRC - Add a line item for recommended inspection items to the safety evaluation template in Enclosure C. (by 12/5/17)

15) NEI - Consistent with action plans tactical objectives for this ISG-06 revision, determine whether the alternate review process should preclude licensees from the role of developing the application, and whether a prerequisite of the alternate review process should be only the approved platform developer (or a third party) may perform application development activities,. Address comment ZD3 - In cases where the development is performed by a vendor: Make an if, then, else statement. based on the determination. (by 12/4/17)

Meeting Handouts ISG-6 R2 MASTER 20171031a Copy (NRC Combined Comments11.9.17) ML17338B095 ISG-6 R2 MASTER 20171031a Copy - BFD DZ 11.14.17 ML17338B123 ISG-6 R2 Draft 20171116.pdf ML17338B140 ISG-06_rev2_D.5 20171114(rjs).docx ML17338B212 ISG-06 Revision Project Plan 11152017.pdf ML17338B223 Meeting Participants Rich Stattel, NRC Samir Darbali, NRC Bernie Dittman, NRC Deanna Zhang, NRC Mike Waters, NRC Brian Thomas, NRC Shana Helton, NRC Steven Arndt, NRC Lynnea Wilkins, NRC John Connelly, Exelon David Hooten, Altran Pareez Golub, Excel Services Dave Herrell, MPR Frank Novak, GEH Ray Herb, SNC Steve Dragouch, Exelon Warren Odess-Gillett, NEI

ML17338B080; *via e-mail NRC-001 OFFICE DLP/PBEB/PM DE/EICB/BC*

RES/DE/ICEEB NRO/DEI/ICE DLP/PLPB/BC DLP/PLPB/PM NAME SWyman MWaters TKoshy IJung DMorey (SSanders for)

LWilkins DATE 3/8/2018 3/12/2018 3/12/2018 3/12/2018 4/30/2018 5/1/2018